DILADEL 60 mg Modified-Release Tablets

Зміст інструкції

1. DILADEL 60 mg modified-release tablets
   1. What is DILADEL and what it is used for
   2. What you need to know before taking DILADEL
   3. How to take DILADEL
   4. Possible side effects
   5. How to store DILADEL
   6. Contents of the pack and other information
2. DILADEL 120 mg prolonged-release tablets
   1. What is DILADEL and what is it used for
   2. What you need to know before taking DILADEL
   3. How to take DILADEL
   4. Possible side effects
   5. How to store DILADEL
   6. Contents of the pack and other information
3. DILADEL 200 mg hard prolonged-release capsules
   1. What is DILADEL and what is it used for
   2. What you need to know before taking DILADEL
   3. How to take DILADEL
   4. Possible side effects
   5. How to store DILADEL
   6. Contents of the pack and other information

DILADEL 60 mg modified-release tablets

Diltiazem hydrochloride

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What DILADEL is and what it is used for
• 2. What you need to know before you take DILADEL
• 3. How to take DILADEL
• 4. Possible side effects
• 5. How to store DILADEL
• 6. Contents of the pack and other information

1. What is DILADEL and what it is used for

DILADEL contains the active substance diltiazem hydrochloride which belongs to a group of medicines
called calcium channel blockers (calcium antagonists), used for the treatment of high blood
pressure.
DILADEL is indicated for the treatment of:

• chest pain (angina pectoris) due to exertion, a heart attack or problems with the arteries that carry blood to the heart (Prinzmetal's angina);
• in cases of mild or moderate high blood pressure.

2. What you need to know before taking DILADEL

Do not take DILADEL

• if you are allergic to diltiazem or any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (systolic pressure less than 90 mmHg);
• if you are experiencing an acute heart attack with lung problems;
• if you have an irregular heartbeat due to certain heart conditions (sick sinus syndrome, atrioventricular block, sinoatrial block) and do not have a functioning pacemaker;
• if you have a very slow heartbeat (severe bradycardia, below 40 beats per minute);
• if you have severe heart problems, possibly with lung problems (left ventricular failure with pulmonary congestion and congestive heart failure);
• if you are using medicines such as dantrolene and amiodarone for infusion (see section “Other medicines and DILADEL”);
• if you are using a medicine containing ivabradine for the treatment of certain heart conditions;
• if you are using a medicine containing lomitapide, used for the treatment of high cholesterol levels (see section “Other medicines and DILADEL”).
• if you are pregnant or suspect you may be pregnant, if you are breastfeeding or if you are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).

Warnings and precautions
Talk to your doctor or pharmacist before taking DILADEL.
Talk to your doctor if you have a history of heart failure, unusual shortness of breath, slow heartbeat or low blood pressure. Cases of kidney damage have been reported in patients with such conditions, and your doctor may need to monitor kidney function.
Use this medicine with great caution and inform your doctor in the following cases:

• if you have heart problems such as reduced left ventricular function, slow heartbeat (bradycardia) or other heart disorders (first-degree atrioventricular block);
• if you are elderly or if you have kidney or liver problems;
• if you are also taking other medicines that lower blood pressure, as blood pressure may drop excessively (see “Other medicines and DILADEL”);
• if you are at risk of intestinal obstruction as diltiazem has effects on bowel function; if you are to undergo surgery, inform the anesthesiologist that you are taking this medicine.

In the cases mentioned, different doses than those normally used may be prescribed to you.
Your doctor will subject you to periodic checks of heart, liver, kidney function (during and especially at the beginning of treatment) and blood sugar levels, if you suffer from diabetes mellitus, as there is a risk of increased blood sugar.
Calcium antagonists, such as diltiazem, may be associated with mood changes, including depression.
The use of DILADEL may cause constriction of the bronchi (bronchospasm), including a worsening of asthma, particularly in patients who already have some difficulty breathing or after increasing the dosage. During therapy with DILADEL, your doctor will perform checks of respiratory function.

Children
This medicine is not recommended for children.
Other medicines and DILADEL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use this medicine in association with:

• dantrolene (infusion), a medicine used for muscle spasms and for the treatment of a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat certain heart conditions;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects.

Use particular caution and inform your doctor if you are taking any of the following medicines (in some cases the doctor may adjust the dose of diltiazem or other medicines):

• antihypertensives, medicines that lower blood pressure. If you are taking this medicine together with an antihypertensive, your doctor will carefully monitor your blood pressure;
• nitrates, medicines that dilate blood vessels. If you are taking this medicine, nitrates will be prescribed at gradually increasing doses;
• theophylline, a medicine used for asthma therapy;
• beta-blockers, medicines used for high blood pressure and heart problems. In this case, the doctor will closely monitor heart function, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers (see section 4);
• heart medicines in general and in particular cardiac glycosides (e.g. digoxin). Take particular care, especially if you are elderly or taking high doses of diltiazem;
• medicines used for heart rhythm problems (antiarrhythmics). In this case, the doctor will closely monitor your heart function;
• carbamazepine and phenytoin, medicines used for epilepsy. In this case, the doctor will monitor the levels of carbamazepine and phenytoin in your blood;
• rifampicin, a medicine for bacterial infections (antibiotic);
• medicines used for stomach ulcers, called H2-antagonists, such as cimetidine and ranitidine. If treatment with these medicines is started or stopped during treatment with DILADEL, the doctor may adjust the dose of diltiazem;
• cyclosporine, a medicine used against organ transplant rejection;
• medicines for depression (antidepressants) such as imipramine and tricyclic antidepressants;
• medicines used for mental disorders (antipsychotics) including lithium;
• medicines used for anesthesia (see section “Warnings and precautions”);
• contrast agents for X-ray examinations, as they may increase the heart effects of diltiazem such as lowering blood pressure;
• antiplatelet agents, medicines that prevent the aggregation of certain blood cells called platelets, increasing blood fluidity;
• benzodiazepines, medicines for depression, such as midazolam, triazolam as diltiazem increases the concentration of these drugs in the blood;
• corticosteroids, medicines used to treat inflammation. Your doctor will monitor you by modifying, if necessary, the dose of corticosteroids;
• statins, medicines used to lower blood cholesterol, because there is a risk of serious muscle damage (myopathy and rhabdomyolysis);
• cilostazol, a medicine used to relieve leg pain when walking. DILADEL increases the activity of cilostazol.

DILADEL with drinks
Avoid taking this medicine together with grapefruit juice as this may increase its effect. If you are taking grapefruit juice, your doctor should monitor for possible side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take DILADEL if you are pregnant, are planning a pregnancy or are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).
Do not take this medicine if you are breastfeeding, as this medicine passes into breast milk.
If you need to take DILADEL, stop breastfeeding.

Driving and using machines
This medicine may affect your ability to drive and operate machinery as it may cause side effects such as feeling unwell and dizziness. If this happens, avoid driving or using machines.

DILADEL contains castor oil
This medicine contains castor oil which may cause stomach upset and diarrhea.

DILADEL contains lactose
This medicine contains a type of sugar called lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take DILADEL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

Treatment of angina pectoris:the recommended dose is 1 tablet 3 times a day, at
regular intervals. If necessary, your doctor may decide to increase the dose to 2 tablets 3 times
a day depending on your condition.

Treatment of high blood pressure (hypertension):the recommended dose ranges from half to 1 tablet
3 times a day.

Use in children
The use of DILADEL is not recommended in children.

Use in elderly people and with kidney or liver problems
If you are elderly or have liver or kidney problems or are taking other medicines for high blood pressure, the
recommended initial dose is half a tablet 3 times a day.

If you take more DILADEL than you should
Symptoms of overdose are: lowering of blood pressure to the point of collapse,
slowing of the heartbeat (bradycardia) and other heart problems (disturbances in atrioventricular
conduction), reduced kidney function.
In case of accidental ingestion/intake of an excessive dose of DILADEL, immediately notify
your doctor or go to the Emergency Room of the nearest hospital.

If you forget to take DILADEL
If you forget to take a tablet, take it as soon as you remember, unless it is almost
time to take the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking DILADEL
Do not abruptly stop treatment with this medicine as it may worsen heart problems
such as angina. Consult your doctor before stopping treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Very common(may affect more than 1 in 10 people)

• swelling due to fluid retention (peripheral edema).

Common(may affect up to 1 in 10 people)

• headache, dizziness;
• serious heart problems such as atrioventricular block, palpitations;
• hot flushes;
• constipation, digestive disorders, stomach pain, nausea;
• skin irritations such as redness (erythema);
• general malaise.

Uncommon(may affect up to 1 in 100 people)

• nervousness, insomnia;
• slowing of the heartbeat (bradycardia);
• feeling of dizziness when getting up, due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhea;
• liver disorders with changes in liver function tests, such as increased aspartate transaminase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) and lactate dehydrogenase (LDH).

Rare(may affect up to 1 in 1,000 people)

• nosebleeds (epistaxis);
• memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
• altered sensitivity of the limbs (paresthesia), ringing in the ears (tinnitus), tremor;
• pain (angina), irregular heartbeat (arrhythmia) which may cause loss of consciousness (syncope);
• dry mouth, altered taste, abdominal pain;
• changes in blood tests such as increased creatine phosphokinase (CPK);
• loss of appetite (anorexia), weight gain;
• increased need to urinate (polyuria), even at night (nocturia);
• skin irritations such as hives, widespread redness (erythema) due to changes in blood vessels (leucocytoclastic vasculitis), small hemorrhages under the skin (petechiae), itching;
• bone and joint pain;
• vision changes (amblyopia) and eye irritation;
• difficulty breathing (dyspnea);
• decreased sexual potency (impotence).

Very rare(may affect up to 1 in 10,000 people)

• kidney problems such as interstitial nephritis;
• decreased number of white blood cells (leukopenia).

Frequency not known(the frequency cannot be estimated from available data)

• decrease in certain blood cells (platelets) and changes in blood coagulation (prolonged bleeding time);
• mood changes (including depression);
• appearance of abnormal movements that disturb gait (extrapyramidal syndrome), dizziness;
• heart problems (sinoatrial block), severe decrease in heart function (congestive heart failure), changes in electrocardiogram results, temporary cessation of cardiac impulse formation at the sinoatrial node (sinus arrest) and cessation of the heart due to the absence of the contraction phase (asystole);
• lowering of blood pressure (hypotension), slowing of the heartbeat (bradycardia) and other heart problems (atrioventricular block at the node) if the medicine is administered intravenously;
• fluid retention (edema), especially in the lower limbs;
• sweating;
• enlargement of the gums (gingival hyperplasia);
• liver inflammation (hepatitis);
• increased blood sugar levels (hyperglycemia);
• skin disorders due to sensitivity to light (including lichenoid keratosis in areas of skin exposed to the sun);
• swelling of the skin and mucous membranes (angioedema);
• various skin diseases, with redness, blisters, scaling, pustules, sweating sometimes accompanied by fever (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, exfoliative dermatitis, acute generalized pustular exanthematous dermatitis, desquamative erythema with or without fever);
• growth of breast tissue in men (gynecomastia);
• decreased muscle strength (asthenia);
• constriction of the bronchi (bronchospasm), including worsening of asthma;
• a condition in which the body's defense system attacks normal tissues causing symptoms such as swollen joints, fatigue and skin rashes (called "lupus-like syndrome").

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store DILADEL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatDILADELcontains

• The active ingredient is diltiazem hydrochloride. One tablet contains 60 mg of diltiazem hydrochloride.
• The other ingredients are: lactose, hydrogenated castor oil, macrogol 6000 and magnesium stearate.

Description of the appearance of DILADEL and contents of the pack
Pack containing 50 divisible modified-release tablets.

Marketing Authorisation Holder
Zentiva Italia S.r.l. – Via P. Paleocapa 7 – 20121 Milano

Manufacturer
Sanofi Winthrop Industrie 30-36, Avenue Gustave Eiffel, Tours (France)

DILADEL 120 mg prolonged-release tablets

Diltiazem hydrochloride

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What DILADEL is and what it is used for
• 2. What you need to know before you take DILADEL
• 3. How to take DILADEL
• 4. Possible side effects
• 5. How to store DILADEL
• 6. Contents of the pack and other information

2. What is DILADEL and what is it used for

DILADEL contains the active ingredient diltiazem hydrochloride, which belongs to a group of medicines
called calcium channel blockers (calcium antagonists), used for the treatment of high blood
pressure.
DILADEL is indicated for the treatment of:

• chest pain (angina pectoris) due to exertion, a heart attack, or problems with the arteries that carry blood to the heart (Prinzmetal's angina);
• in cases of mild or moderate high blood pressure.

2. What you need to know before taking DILADEL

Do not take DILADEL

• if you are allergic to diltiazem or any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (systolic pressure less than 90 mmHg);
• if you have an acute heart attack with lung problems;
• if you have an irregular heartbeat due to certain heart diseases (sick sinus syndrome, atrioventricular block, sinoatrial block) and do not have a functioning pacemaker;
• if you have a very slow heartbeat (severe bradycardia, below 40 beats per minute);
• if you have severe heart problems, possibly with lung problems (left ventricular failure with pulmonary congestion and congestive heart failure);
• if you are using medicines such as dantrolene and amiodarone for infusion (see section “Other medicines and DILADEL”);
• if you are using a medicine containing ivabradine for the treatment of certain heart diseases;
• if you are using a medicine containing lomitapide, used for the treatment of high cholesterol levels (see section “Other medicines and DILADEL”).
• if you are pregnant or suspect you are pregnant, if you are breastfeeding or if you are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).

Warnings and precautions
Talk to your doctor or pharmacist before taking DILADEL.
Talk to your doctor if you have a history of heart failure, unusual shortness of breath, slow heartbeat or low blood pressure. Cases of kidney damage have been reported in patients with such conditions, the doctor may need to monitor kidney function.
Use this medicine with great caution and inform your doctor in the following cases:

• if you have heart problems such as reduced functioning of the left ventricle, slow heartbeat (bradycardia) or other heart disorders (first-degree atrioventricular block);
• if you are elderly or if you have kidney or liver problems;
• if you are also taking other medicines that lower blood pressure as blood pressure may drop excessively (see “Other medicines and DILADEL”);
• if you are at risk of intestinal obstruction, as diltiazem has effects on bowel function; if you are to undergo surgery, in this case inform the anesthesiologist that you are taking this medicine.

In the cases mentioned, different doses than those normally used may be prescribed to you.
Your doctor will subject you to periodic checks of heart, liver, kidney function (during and especially at the beginning of treatment) and blood sugar levels, if you suffer from diabetes mellitus, as there is a risk of increased blood sugar.
Calcium antagonists, such as diltiazem, may be associated with changes in mood, including depression.
During treatment with this medicine you may notice the presence of parts of the tablets in your stools. This is normal and does not indicate a lack of efficacy of the medicine.
The use of DILADEL may cause constriction of the bronchi (bronchospasm), including a worsening of asthma, especially in those patients who already have some difficulty breathing or after increasing the dosage. During therapy with DILADEL your doctor will subject you to checks of respiratory function.

Children
This medicine is not recommended for children.
Other medicines and DILADEL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use this medicine in combination with:

• dantrolene (infusion), a medicine used for muscle spasms and for the treatment of a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat certain heart diseases;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects.

Use particular caution and inform your doctor if you are taking any of the following medicines (in some cases your doctor may adjust the dose of diltiazem or other medicines):

• antihypertensives, medicines that lower blood pressure. If you are taking this medicine together with an antihypertensive, your doctor will carefully monitor your blood pressure;
• nitrates, medicines that dilate blood vessels. If you are taking this medicine, nitrates will be prescribed at gradually increasing doses;
• theophylline, a medicine used for asthma therapy;
• beta-blockers, medicines used for high blood pressure and heart problems. In this case, the doctor will closely monitor heart function, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers (see section 4);
• heart medicines in general and in particular cardiac glycosides (e.g. digoxin). Pay particular attention especially if you are elderly or if you take high doses of diltiazem;
• medicines used for heart rhythm problems (antiarrhythmics). In this case, the doctor will closely monitor the function of your heart;
• carbamazepine and phenytoin, medicines used for epilepsy. In this case, the doctor will monitor the levels of carbamazepine and phenytoin in the blood;
• rifampicin, a medicine for bacterial infections (antibiotic);
• medicines used for stomach ulcers, called H2-blockers, such as cimetidine and ranitidine. If treatment with these medicines is started or stopped during treatment with DILADEL, the doctor may adjust the dose of DILADEL;
• cyclosporine, a medicine used against organ transplant rejection;
• medicines for depression (antidepressants) such as imipramine and tricyclic antidepressants;
• medicines used for mental disorders (antipsychotics) including lithium;
• medicines used for anesthesia (see section “Warnings and precautions”);
• contrast agents for X-ray examination, as they can increase the heart effects of diltiazem such as lowering blood pressure;
• antiplatelet agents, medicines that prevent the aggregation of certain blood cells called platelets, increasing blood fluidity;
• benzodiazepines, medicines for depression, such as midazolam, triazolam, as diltiazem increases the concentration of these drugs in the blood;
• corticosteroids, medicines used to treat inflammation. Your doctor will monitor you by adjusting the dose of corticosteroids, if necessary;
• statins, medicines used to lower cholesterol in the blood, as there may be a risk of serious muscle damage (myopathy and rhabdomyolysis); cilostazol, a medicine used to relieve leg pain when walking. DILADEL increases the activity of cilostazol.

DILADEL with drinks
Avoid taking this medicine together with grapefruit juice as this may increase its effect.
If you are taking grapefruit juice, your doctor should check for possible side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take DILADEL if you are pregnant, planning a pregnancy or are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).
Do not take this medicine if you are breastfeeding, as this medicine passes into breast milk.
If you need to take DILADEL, stop breastfeeding.

Driving and using machines
This medicine may affect your ability to drive and operate machinery as it may cause side effects such as malaise and dizziness. If this happens, avoid driving or using machines.

DILADEL contains sucrose
This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take DILADEL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

Treatment of angina pectoris and high blood pressure:the recommended dose is 1 tablet every 12 hours.
This medicine is intended for maintenance therapy.
Do not chew the tablets, but swallow them whole with a little water.

Use in children
The use of DILADEL is not recommended in children.

Use in the elderly and with kidney or liver problems
If you are elderly or have liver or kidney problems or are taking other medicines for high blood pressure, the recommended initial dose is the minimum effective dose.

If you take more DILADEL than you should
Symptoms of overdose are: lowering of blood pressure up to collapse,
slowing of the heartbeat (bradycardia) and other heart problems (disturbances in atrioventricular conduction), reduced kidney function.
In case of accidental ingestion/intake of an excessive dose of DILADEL, immediately inform your doctor or go to the Emergency Room of the nearest hospital.

If you forget to take DILADEL
If you forget to take a tablet, do so as soon as you remember, unless it is almost time to take the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking DILADEL
Do not abruptly stop treatment with this medicine because it may worsen heart problems such as angina. Consult your doctor before stopping treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Very common(may affect more than 1 in 10 people)

• swelling due to fluid retention (peripheral edema).

Common(may affect up to 1 in 10 people)

• headache, dizziness;
• serious heart problems such as atrioventricular block, palpitations;
• hot flushes;
• constipation, digestive disorders, stomach pain, nausea;
• skin irritations such as redness (erythema);
• general feeling of discomfort.

Uncommon (may affect up to 1 in 100 people)

• nervousness, insomnia;
• slowing of the heartbeat (bradycardia);
• feeling of dizziness when standing up due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhea;
• liver disorders with changes in blood tests related to the liver, such as increased aspartate transaminase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and lactate dehydrogenase (LDH).

Rare(may affect up to 1 in 1,000 people)

• nosebleeds (epistaxis);
• memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
• altered sensitivity of the limbs (paresthesia), ringing in the ears (tinnitus), tremor;
• pain (angina), irregular heartbeat (arrhythmia) which can lead to loss of consciousness (syncope);
• dry mouth, altered taste, abdominal pain;
• changes in blood tests such as increased creatine phosphokinase (CPK);
• loss of appetite (anorexia), weight gain;
• increased need to urinate (polyuria), even at night (nocturia);
• skin irritations such as hives, widespread redness (erythema) due to changes in blood vessels (leucocytoclastic vasculitis), small hemorrhages under the skin (petechiae), itching;
• bone and joint pain;
• vision changes (amblyopia) and eye irritation;
• difficulty breathing (dyspnea);
• decreased sexual potency (impotence).

Very rare(may affect up to 1 in 10,000 people)

• kidney problems such as interstitial nephritis;
• decreased number of white blood cells (leukopenia).

Frequency not known(the frequency cannot be estimated from available data)

• decrease in certain blood cells (platelets) and changes in blood coagulation (prolonged bleeding time);
• mood changes (including depression);
• appearance of abnormal movements that disturb gait (extrapyramidal syndrome), dizziness;
• heart problems (sinoatrial block), severe decrease in heart function (congestive heart failure), changes in electrocardiogram results, temporary cessation of cardiac impulse formation at the sinoatrial node (sinus arrest) and cessation of the heart due to the absence of the contraction phase (asystole);
• lowering of blood pressure (hypotension), slowing of the heartbeat (bradycardia) and other heart problems (atrioventricular block at the node) if the medicine is administered intravenously;
• fluid retention (edema), especially in the lower limbs;
• sweating;
• enlargement of the gums (gingival hyperplasia);
• liver inflammation (hepatitis);
• increased blood sugar levels (hyperglycemia);
• skin disorders due to light sensitivity (including lichenoid keratosis in areas of skin exposed to the sun);
• swelling of the skin and mucous membranes (angioedema);
• various skin diseases, with redness, blisters, scaling, pustules, sweating sometimes accompanied by fever (multiforme erythema, Stevens-Johnson syndrome and toxic epidermal necrolysis, exfoliative dermatitis, acute generalized pustular exanthematous dermatitis, desquamative erythema with or without fever);
• growth of breast tissue in men (gynecomastia);
• decreased muscle strength (asthenia);
• constriction of the bronchi (bronchospasm), including a worsening of asthma;
• a condition in which the body's defense system attacks normal tissues causing symptoms such as swollen joints, fatigue and skin rashes (called "lupus-like syndrome").

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store DILADEL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “exp.”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatDILADELcontains

• The active ingredient is diltiazem hydrochloride. One tablet contains 120 mg of diltiazem hydrochloride.
• The other ingredients are: Tablet core: sodium citrate monobasic, sucrose, povidone, macrogol 6000 and magnesium stearate. Tablet coating: sucrose, modified PVC, acetylbutylcitrate, sodium bicarbonate, ethyl vanillin, titanium dioxide (E171).

Description of the appearance of DILADEL and contents of the pack
Pack containing 24 prolonged-release tablets.

Marketing Authorisation Holder
Zentiva Italia S.r.l. – Via P. Paleocapa 7 – 20121 Milano

Manufacturer
Sanofi Winthrop Industrie, 30-36 Avenue Gustave Eiffel, Tours (France)

DILADEL 200 mg hard prolonged-release capsules

DILADEL 300 mg hard prolonged-release capsules
Diltiazem hydrochloride

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What DILADEL is and what it is used for
• 2. What you need to know before you take DILADEL
• 3. How to take DILADEL
• 4. Possible side effects
• 5. How to store DILADEL
• 6. Contents of the pack and other information

1. What is DILADEL and what is it used for

DILADEL contains the active substance diltiazem hydrochloride which belongs to a group of medicines
called calcium channel blockers (calcium antagonists), used for the treatment of high blood
pressure.
DILADEL is indicated for the treatment of:

• chest pain (angina pectoris) due to exertion, a heart attack or problems with the arteries that carry blood to the heart (Prinzmetal's angina);
• in cases of mild to moderate high blood pressure.

2. What you need to know before taking DILADEL

Do not take DILADEL

• if you are allergic to diltiazem or any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (systolic pressure less than 90 mmHg);
• if you have an acute heart attack with lung problems;
• if you have an irregular heartbeat due to certain heart conditions (sick sinus syndrome, atrioventricular block, sinoatrial block) and do not have a functioning pacemaker;
• if you have a very slow heartbeat (severe bradycardia, below 40 beats per minute);
• if you have severe heart problems, possibly with lung problems (left ventricular failure with pulmonary congestion and congestive heart failure);
• if you are using medicines such as dantrolene and amiodarone for infusion (see section “Other medicines and DILADEL”);
• if you are using a medicine containing ivabradine for the treatment of certain heart diseases;
• if you are using a medicine containing lomitapide, used for the treatment of high cholesterol levels (see section “Other medicines and DILADEL”).
• if you are pregnant or suspect you may be pregnant, if you are breastfeeding or if you are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).

Warnings and precautions
Talk to your doctor or pharmacist before taking DILADEL.
Talk to your doctor if you have a history of heart failure, unusual shortness of breath, slow heartbeat or low blood pressure. Cases of kidney damage have been reported in patients with such conditions, the doctor may need to monitor kidney function.
Use this medicine with great caution and inform your doctor in the following cases:

• if you have heart problems such as reduced function of the left ventricle, slow heartbeat (bradycardia) or other heart disorders (first-degree atrioventricular block);
• if you are elderly or if you have kidney or liver problems;
• if you are also taking other medicines that lower blood pressure, as blood pressure may drop excessively (see “Other medicines and DILADEL”);
• if you are at risk of intestinal obstruction as diltiazem has effects on bowel function;
• if you are going to have surgery, in which case inform the anesthesiologist that you are taking this medicine.

In the cases mentioned, different doses than those normally used may be prescribed to you.
Your doctor will subject you to periodic checks of heart, liver, kidney function (during and especially at the beginning of treatment) and blood sugar levels, if you suffer from diabetes mellitus, as there is a risk of increased blood sugar.
Calcium antagonists, such as diltiazem, may be associated with changes in mood, including depression.
The use of DILADEL may cause constriction of the bronchi (bronchospasm), including a worsening of asthma, especially in those patients who already have some difficulty breathing or after an increase in dosage. During therapy with DILADEL, your doctor will subject you to checks of respiratory function.

Children
This medicine is not recommended for children.
Other medicines and DILADEL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use this medicine in association with:

• dantrolene (infusion), a medicine used for muscle spasms and for the treatment of a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat certain heart diseases;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects.

Use particular caution and inform your doctor if you are taking any of the following medicines (in some cases the doctor may adjust the dose of diltiazem or other medicines):

• antihypertensives, medicines that lower blood pressure. If you are taking this medicine together with an antihypertensive, the doctor will carefully monitor your blood pressure;
• nitrates, medicines that dilate blood vessels. If you are taking this medicine, nitrates will be prescribed at gradually increasing doses;
• theophylline, a medicine used for asthma therapy;
• beta-blockers, medicines used for high blood pressure and heart problems. In this case, the doctor will closely monitor heart function, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers (see section 4);
• heart medicines in general and in particular cardiac glycosides (e.g. digoxin). Take particular care especially if you are elderly or if you take high doses of diltiazem;
• medicines used for heart rhythm problems (antiarrhythmics). In this case, the doctor will closely monitor the function of your heart;
• carbamazepine and phenytoin, medicines used for epilepsy. In this case, the doctor will monitor the levels of carbamazepine and phenytoin in the blood;
• rifampicin, a medicine for bacterial infections (antibiotic);
• medicines used for stomach ulcers, called H2 antagonists, such as cimetidine and ranitidine. If treatment with these medicines is started or stopped during treatment with DILADEL, the doctor may adjust the dose of diltiazem;
• cyclosporine, a medicine used against organ rejection;
• medicines for depression (antidepressants) such as imipramine and tricyclic antidepressants;
• medicines used for mental disorders (antipsychotics) including lithium;
• medicines used for anesthesia (see section “Warnings and precautions”);
• contrast agents for X-ray examination, as they may increase the effects on the heart of diltiazem such as lowering blood pressure;
• antiplatelet agents, medicines that prevent the aggregation of certain blood cells called platelets, increasing blood fluidity;
• benzodiazepines, medicines for depression, such as midazolam, triazolam, as diltiazem increases the concentration of these drugs in the blood;
• corticosteroids, medicines used to treat inflammation. Your doctor will monitor you, modifying the dose of corticosteroids if necessary;
• statins, medicines used to lower cholesterol in the blood; because there may be a risk of severe muscle damage (myopathy and rhabdomyolysis);
• cilostazol, a medicine used to relieve leg pain when walking. DILADEL increases the activity of cilostazol.

DILADEL with food and drink
Avoid taking this medicine together with grapefruit juice as this may increase its effect.
If you are taking grapefruit juice, your doctor should monitor for possible side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take DILADEL if you are pregnant, planning a pregnancy or if you are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives).
Do not take this medicine if you are breastfeeding, as this medicine passes into breast milk.
If you need to take DILADEL, stop breastfeeding.

Driving and operating machinery
This medicine may affect your ability to drive and operate machinery because it can cause side effects such as feeling unwell and dizziness. If this happens, avoid driving or using machinery.

3. How to take DILADEL

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.

Treatment of angina pectoris and high blood pressure:the recommended initial dose is 1 capsule
of 200 mg per day. If necessary, your doctor may decide to increase the dose to 1 capsule of 300
mg per day depending on your condition.
This medicine is indicated for maintenance therapy.
Do not chew the capsules, but swallow them whole with a little water, preferably before or during
a meal consistently.

Use in children
The use of DILADEL is not recommended in children.

Use in elderly people and with kidney or liver problems
If you are elderly or have liver or kidney problems or are taking other medicines for high blood pressure, the dose
recommended initial dose is 1 capsule of 200 mg per day.

If you take more DILADEL than you should
The symptoms of overdose are: lowering of blood pressure to collapse,
slowing of the heartbeat (bradycardia) and other heart problems (disturbances in atrio-ventricular
conduction), reduced kidney function.
In case of accidental ingestion/intake of an excessive dose of DILADEL, immediately inform
your doctor or go to the Emergency Room of the nearest hospital.

If you forget to take DILADEL
If you forget to take a capsule, do so as soon as you remember, unless it is almost time
to take the next dose. Do not take a double dose to compensate for forgetting the
dose.

If you stop taking DILADEL
Do not abruptly stop treatment with this medicine as it may worsen heart problems
such as angina. Consult your doctor before stopping treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Very common(may affect more than 1 in 10 people)

• swelling due to fluid retention (peripheral edema).

Common(may affect up to 1 in 10 people)

• headache, dizziness;
• serious heart problems such as atrioventricular block, palpitations;
• hot flushes;
• constipation, digestive disorders, stomach pain, nausea;
• skin irritations such as redness (erythema);
• general malaise.

Uncommon(may affect up to 1 in 100 people)

• nervousness, insomnia;
• slowing of the heartbeat (bradycardia);
• feeling of dizziness when getting up due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhea;
• liver disorders with changes in blood tests related to the liver, such as increased aspartate transaminase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and lactic dehydrogenase (LDH).

Rare(may affect up to 1 in 1,000 people)

• nosebleeds (epistaxis);
• memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
• altered sensitivity of the limbs (paresthesia), ringing in the ears (tinnitus), tremor;
• chest pain (angina), irregular heartbeat (arrhythmia) which may cause loss of consciousness (syncope);
• dry mouth, altered taste, abdominal pain;
• changes in blood tests such as increased creatine phosphokinase (CPK);
• loss of appetite (anorexia), weight gain;
• increased need to urinate (polyuria), even at night (nocturia);
• skin irritations such as hives, redness (erythema) generalized due to changes in blood vessels (leucocytoclastic vasculitis), small hemorrhages under the skin (petechiae), itching;
• bone and joint pain;
• vision changes (amblyopia), eye irritation;
• difficulty breathing (dyspnea);
• decreased sexual potency (impotence).

Very rare(may affect up to 1 in 10,000 people)

• kidney problems such as interstitial nephritis;
• decreased number of white blood cells (leukopenia).

Frequency not known(the frequency cannot be estimated from the available data)

• decrease in certain blood cells (platelets) and changes in blood clotting (prolonged bleeding time);
• mood changes (including depression);
• appearance of abnormal movements that disturb gait (extrapyramidal syndrome), dizziness;
• heart problems (sinoatrial block), severe decrease in heart function (congestive heart failure), changes in electrocardiogram results, temporary cessation of the cardiac impulse formation at the sinoatrial node (sinus arrest) and cardiac arrest due to the absence of the contraction phase (asystole);

temporary cessation of the formation of the cardiac impulse at the level of the sinus node (sinus arrest) and cardiac arrest due to the absence of the contraction phase (asystole);

• lowering of blood pressure (hypotension), slowing of the heartbeat (bradycardia) and other heart problems (atrioventricular block at the node level) if the medicine is administered intravenously;
• fluid retention (edema), especially in the lower limbs;
• sweating;
• enlargement of the gums (gingival hyperplasia);
• liver inflammation (hepatitis);
• increased blood sugar levels (hyperglycemia);
• skin disorders due to sensitivity to light (including lichenoid keratosis in areas of skin exposed to the sun);
• swelling of the skin and mucous membranes (angioedema);
• various skin diseases, with redness, blisters, scaling, pustules, sweating sometimes accompanied by fever (erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis, exfoliative dermatitis, acute generalized exanthematous pustular dermatitis, desquamative erythema with or without fever);
• growth of breast tissue in men (gynecomastia);
• decreased muscle strength (asthenia);
• constriction of the bronchi (bronchospasm), including worsening of asthma;
• a condition in which the body's defense system attacks normal tissues causing symptoms such as swollen joints, fatigue and skin rashes (called "lupus-like syndrome").

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store DILADEL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “exp.”.
The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 30°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

WhatDILADEL contains
DILADEL 200 mg prolonged-release hard capsules
Each capsule contains a mixture of immediate-release and prolonged-release microgranules.

• The active ingredient is diltiazem hydrochloride. One capsule contains 200 mg of diltiazem hydrochloride.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose, acrylic and methacrylic ester copolymer, ethylcellulose, acetylated monoglycerides and magnesium stearate. Capsule composition: gelatin, titanium dioxide (E171), iron oxides (E172).

DILADEL 300 mg prolonged-release hard capsules
Each capsule contains a mixture of immediate-release and prolonged-release microgranules.

• The active ingredient is diltiazem hydrochloride. One capsule contains 300 mg of diltiazem hydrochloride.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose, acrylic and methacrylic ester copolymer, ethylcellulose, acetylated monoglycerides and magnesium stearate. Capsule composition: gelatin, titanium dioxide (E171), iron oxides (E172).

Description of the appearance of DILADEL and contents of the pack
DILADEL 200 mg prolonged-release hard capsules
Pack containing 36 capsules.

DILADEL 300 mg prolonged-release hard capsules
Pack containing 14 capsules.

Marketing Authorisation Holder
Zentiva Italia S.r.l. – Via P. Paleocapa 7 – 20121 Milano

Manufacturer
Sanofi Winthrop Industrie 30-36, Avenue Gustave Eiffel, Tours (France)
Delpharm Dijon, 6 Boulevard De L’Europe, Quétigny (France)